Patient Mobility and Outcomes After Cardiac Surgery
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2019 |
| Start Date: | March 28, 2018 |
| End Date: | May 30, 2020 |
Patient Mobility and Outcomes After Cardiac Surgery: A Randomized Controlled Trial
Standards for post-cardiac surgery physical interventions vary between insitutions and there
are no published guidelines for national organizations in the U.S. The increasing body of
evidence for the effectiveness of physical interventions coupled with variability in how
these interventions are implemented suggests a critical need to prospectively determine the
impact of clearly defined postoperative physical interventions. This randomized, controlled
study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative
physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and
ambulation, and 3) patient education on the outcomes of hospital lengths of stay and
discharge disposition. The investigators will enroll 220 adult subjects undergoing elective
CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined
CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care)
group or intervention group (enhanced protocol), and followed for five days. Subjects in each
group will wear a FitBit Charge 2 for the duration of the five days following surgery. This
will provide both sleep activity and steps data that will be analyzed for sleep quality and
distance walked. The primary aim is to assess the difference between groups for ICU and
hospital length of stay.
are no published guidelines for national organizations in the U.S. The increasing body of
evidence for the effectiveness of physical interventions coupled with variability in how
these interventions are implemented suggests a critical need to prospectively determine the
impact of clearly defined postoperative physical interventions. This randomized, controlled
study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative
physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and
ambulation, and 3) patient education on the outcomes of hospital lengths of stay and
discharge disposition. The investigators will enroll 220 adult subjects undergoing elective
CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined
CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care)
group or intervention group (enhanced protocol), and followed for five days. Subjects in each
group will wear a FitBit Charge 2 for the duration of the five days following surgery. This
will provide both sleep activity and steps data that will be analyzed for sleep quality and
distance walked. The primary aim is to assess the difference between groups for ICU and
hospital length of stay.
Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study
staff will visit potential study subjects in the pre-surgical testing clinic to discuss the
study's objectives and to ascertain subjects' interest in participating in the study. After
providing informed consent, subjects will be randomized using SAS into either the
interventional group or standard care group after their surgical procedure is complete and
the subject has been transferred to the CVICU. After completion of the surgical procedure,
patients who had a major perioperative complication such as stroke, myocardial infarction,
pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs),
intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen
failures and will not be randomized, since the investigators consider the patient enrolled
once randomized. Patients randomized to the interventional group will undergo the enhanced
physical therapy protocol which includes mobilization from bed to chair on the day of surgery
and more frequent ambulation on the subsequent five days.
The main differences between the standard therapy (control) group and intervention group is
the timing of post-operative mobilization and ambulation, as well as the point at which they
receive gait and safe ambulation training. In the standard therapy group, the patients will
receive a FitBit2 after their arrival on the ICU, withstanding any postoperative
complications. On POD 1 the subjects routinely get up to the bedside chair with the help of
an ICU nurse or physical therapist. The subjects will generally ambulate one-half the
circumference of the ICU with assistance, though this is not enforced. On POD2 and onward,
the standard therapy group typically will get up to the bedside chair at least once, as well
as walk one-half circumference of the ICU, and will receive the standard physical therapy
gait and ambulation training. The intervention group will have the FitBit2 watch placed on
their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will
get up to the bedside chair twice (as tolerated by patient), and will be asked to walk
one-half the ICU circumference. Additionally, the patient's physical therapy and
gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the
bedside chair three times, and will be asked to attempt three walks with the goal of one full
ICU circumference.
staff will visit potential study subjects in the pre-surgical testing clinic to discuss the
study's objectives and to ascertain subjects' interest in participating in the study. After
providing informed consent, subjects will be randomized using SAS into either the
interventional group or standard care group after their surgical procedure is complete and
the subject has been transferred to the CVICU. After completion of the surgical procedure,
patients who had a major perioperative complication such as stroke, myocardial infarction,
pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs),
intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen
failures and will not be randomized, since the investigators consider the patient enrolled
once randomized. Patients randomized to the interventional group will undergo the enhanced
physical therapy protocol which includes mobilization from bed to chair on the day of surgery
and more frequent ambulation on the subsequent five days.
The main differences between the standard therapy (control) group and intervention group is
the timing of post-operative mobilization and ambulation, as well as the point at which they
receive gait and safe ambulation training. In the standard therapy group, the patients will
receive a FitBit2 after their arrival on the ICU, withstanding any postoperative
complications. On POD 1 the subjects routinely get up to the bedside chair with the help of
an ICU nurse or physical therapist. The subjects will generally ambulate one-half the
circumference of the ICU with assistance, though this is not enforced. On POD2 and onward,
the standard therapy group typically will get up to the bedside chair at least once, as well
as walk one-half circumference of the ICU, and will receive the standard physical therapy
gait and ambulation training. The intervention group will have the FitBit2 watch placed on
their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will
get up to the bedside chair twice (as tolerated by patient), and will be asked to walk
one-half the ICU circumference. Additionally, the patient's physical therapy and
gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the
bedside chair three times, and will be asked to attempt three walks with the goal of one full
ICU circumference.
Inclusion Criteria:
- Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft
(CABG) surgery, mitral valve repair or replacement surgery, aortic valve repair or
replacement surgery and combined CABG with one or more valve repair or replacement
surgery.
Exclusion Criteria:
- Those who do not med the inclusion criteria
- Pregnant women
- Prisoners
- Those patients with skin or systemic infections
- Those patients who are paraplegic or quadriplegic
- Those patients who have allergies to polyurethane
- Any patient who experiences perioperative complications (e.g., stroke, myocardial
infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of
PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest
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